Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel

Phase 4

Completed

Brief Summary: This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.

Detailed Description: This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.

Recruitment & Eligibility

Inclusion Criteria

Outpatient, male or female subjects of any race, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
Facial acne vulgaris characterized by the following:

IGA Score >3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial non-inflammatory lesions (open/closed comedones)

Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA Authorization forms

Exclusion Criteria

Female subjects who are pregnant (positive urine pregnancy test), breast feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
Allergy/sensitivity to any component of the test treatment (Section 5.2), lincomycin, tetracyclines, or sulfites.
Subjects who have not complied with the proper wash-out periods for prohibited medications/procedures (Supplement 1)>
History of clinically significant anemia or hemolysis.
History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis).
Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
Evidence of recent alcohol or drug abuse
Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
History of poor cooperation, non-compliance with medical treatment or unreliability
Participation in an investigational drug study within 30 days of the baseline visit.

Arm && Interventions

Group	Intervention	Description
doxy + aczone	Doxycycline 100mg	Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response
doxy + aczone	Aczone 5% gel	Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily and those who improve significantly are continued on Aczone gel alone to see if it can maintain therapeutic response

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Remained Responders at Week 24	Assessed every 4 weeks, reported at Week 24	At week 12 responder had an IGA \<3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained

Secondary Outcome Measures

Name	Time	Method
Peeling	every four weeks	the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling
Percentage of Participants Who Are Responders at Week 16 and 20	Assessed every 4 weeks, reported at weeks 16 and 20	Responders is the percentage of participants who have an IGA \<3 at Week 16 and 20
Nodule Counts	every four weeks	number of nodules counted
Dryness	every 4 weeks	the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness
Erythema	every 4 weeks	the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema
Pruritis	every 4 weeks	the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis
Inflammatory and Non-inflammatory Lesion Counts	Every 4 weeks
Oiliness	every 4 weeks	the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness
Burning	every 4 weeks	the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning